{"id":105508,"date":"2019-03-21T00:00:50","date_gmt":"2019-05-17T09:04:07","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/105508\/"},"modified":"2019-05-17T17:04:10","modified_gmt":"2019-05-17T09:04:10","slug":"78e1454d2f","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/105508\/","title":{"rendered":"\u590d\u5b8f\u6c49\u9716\uff1a\u5982\u4f55\u4ece\u751f\u7269\u79d1\u6280\u516c\u53f8\u4e2d\u8131\u9896\u800c\u51fa\uff1f"},"content":{"rendered":"
\n

\u4e00\u3001\u5341\u5e74\u78e8\u4e00\u5251\uff1a\u56fd\u5185\u9996\u4e2a\u751f\u7269\u7c7b\u4f3c\u836f\u4e0a\u5e02<\/span><\/p>\n

1.1 \u5173\u4e8e\u6c49\u5229\u5eb7<\/span><\/p>\n

2019\u5e742\u670825\u65e5\uff0c\u590d\u5b8f\u6c49\u9716\u7684HLX01(\u6c49\u5229\u5eb7)\u6b63\u5f0f\u83b7\u6279\u4e0a\u5e02\uff0c\u8fd9\u662f\u56fd\u5185\u7b2c\u4e00\u4e2a\u6309\u7167\u300a\u751f\u7269\u7c7b\u4f3c\u836f\u6307\u5bfc\u539f\u5219\u300b\u8fdb\u884c\u7814\u5236\u7684\u5355\u6297\uff0c\u5bf9\u4e8e\u56fd\u5185\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u884c\u4e1a\u6765\u8bf4\u5177\u6709\u91cc\u7a0b\u7891\u610f\u4e49\u3002<\/span><\/p>\n

HLX01\u4f5c\u4e3a\u5229\u59a5\u6614\u5355\u6297\u7684\u9996\u4e2a\u751f\u7269\u7c7b\u4f3c\u836f\uff0c\u83b7\u6279\u540e\u4e3b\u8981\u7528\u4e8e\u6cbb\u7597\u5f25\u6f2b\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\u3002\u76ee\u524d\u56fd\u5185\u7684CD20\u5355\u6297\u53ea\u6709\u7f57\u6c0f\u7684\u539f\u7814\u836f\u5229\u59a5\u6614\u5355\u6297\uff0c2017\u5e74PDB\u6837\u672c\u533b\u9662\u7684\u9500\u552e\u989d\u7ea610.8\u4ebf\u5143\uff0c\u540c\u671f\u5168\u7403\u5e02\u573a\u8fbe\u523075\u4ebf\u7f8e\u5143\u3002<\/span><\/p>\n

\u968f\u77402017\u5e74\u5229\u59a5\u6614\u5355\u6297\u964d\u4ef7\u8fdb\u5165\u533b\u4fdd\uff0c\u4ee5\u6c49\u5229\u5eb7\u4e3a\u9996\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u9010\u6b65\u4e0a\u5e02\uff0c\u4f30\u8ba1\u56fd\u5185\u7684\u8bb8\u591a\u5c1a\u672a\u88ab\u6ee1\u8db3\u7684\u4e34\u5e8a\u9700\u6c42\u5f00\u59cb\u7206\u53d1\u3002\u5177\u4f53\u6765\u8bf4\uff0c\u5982\u679c\u6211\u4eec\u4f30\u7b97\u964d\u4ef7\u524d\u540eCD20\u5355\u6297\u5e74\u4f7f\u7528\u8d39\u7528\u5206\u522b\u7ea620\u4e07\u548c15\u4e07\uff0c\u90a3\u4e482017\u5e74\u9500\u552e\u989d\u5bf9\u5e94\u7684\u60a3\u8005\u4ec5\u7ea61\u4e07\uff0c\u6e17\u900f\u7387\u4e0d\u52301\/3\u3002\u603b\u4e4b\uff0cCD20\u5355\u6297\u7b49\u591a\u4e2a\u70ed\u95e8\u9776\u70b9\u5355\u6297\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u90fd\u8fd8\u6709\u5f88\u5927\u7684\u5e02\u573a\u7a7a\u95f4\u3002<\/span><\/p>\n

1.2 \u751f\u7269\u7c7b\u4f3c\u836f\u77e5\u591a\u5c11\uff1f<\/span><\/p>\n

\u751f\u7269\u7c7b\u4f3c\u836f\u5c31\u662f\u5728\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u4e09\u4e2a\u65b9\u9762\u548c\u5df2\u83b7\u51c6\u6ce8\u518c\u7684\u53c2\u7167\u836f\u6ca1\u6709\u4e34\u5e8a\u610f\u4e49\u4e0a\u7684\u5dee\u5f02\uff0c\u800c\u4e14\u5177\u6709\u9ad8\u76f8\u4f3c\u6027\u7684\u6cbb\u7597\u7528\u751f\u7269\u5236\u54c1\u3002\u6bd4\u5982\u590d\u5b8f\u6c49\u9716\u7684\u6c49\u5229\u5eb7\u4e0e\u7f57\u6c0f\u7684\u7f8e\u7f57\u534e\uff0c\u4e8c\u8005\u5728\u7597\u6548\u3001\u6210\u5206\u7b49\u65b9\u9762\u5747\u6ca1\u6709\u4e34\u5e8a\u4e0a\u7684\u5dee\u5f02\u3002<\/span><\/p>\n

\u65e0\u8bba\u662f\u4e34\u5e8a\u7814\u53d1\u3001\u8fd8\u662f\u5927\u89c4\u6a21\u751f\u4ea7\uff0c\u751f\u7269\u7c7b\u4f3c\u836f\u5747\u5b58\u5728\u8f83\u9ad8\u7684\u65f6\u95f4\u4e0e\u6280\u672f\u58c1\u5792\uff0c\u8fd9\u4e5f\u662f\u751f\u7269\u7c7b\u4f3c\u836f\u76f8\u6bd4\u666e\u901a\u5316\u5b66\u4eff\u5236\u836f\uff0c\u901a\u5e38\u80fd\u591f\u62e5\u6709\u66f4\u597d\u7684\u7ade\u4e89\u683c\u5c40\u3001\u5236\u5b9a\u66f4\u9ad8\u7684\u4ef7\u683c\u7684\u539f\u56e0\u3002<\/span><\/p>\n

1.3 \u751f\u7269\u7c7b\u4f3c\u836f\u7684\u5546\u4e1a\u6f5c\u529b<\/span><\/p>\n

\u4f17\u6240\u5468\u77e5\uff0c\u5355\u6297\u836f\u7269\u662f\u76ee\u524d\u4e16\u754c\u4e0a\u6700\u7545\u9500\u7684\u836f\u7269\u54c1\u7c7b\uff0c\u540c\u65f6\u4e5f\u662f\u4e2d\u56fd\u672a\u6765\u589e\u957f\u6f5c\u529b\u6700\u5927\u7684\u836f\u7269\u54c1\u7c7b\u4e4b\u4e00\u30022017\u5e74\u5168\u7403\u5355\u6297\u836f\u5e02\u573a\u89c4\u6a21\u7ea61038\u4ebf\u7f8e\u5143\uff0c\u540c\u671f\u4e2d\u56fd\u5e02\u573a\u53ea\u6709118\u4ebf\u5143\u3002\u540c\u65f6\u968f\u7740\u539f\u7814\u836f\u4e13\u5229\u9010\u6e10\u5230\u671f\uff0c\u751f\u7269\u7c7b\u4f3c\u836f\u5728\u5355\u6297\u5185\u90e8\u7684\u5360\u6bd4\u4e5f\u8d8a\u6765\u8d8a\u9ad8\u3002<\/span><\/p>\n

\u6b63\u5982\u524d\u6587\u6240\u8ff0\u7684\u6c49\u5229\u5eb7\u4e00\u6837\uff0c\u6574\u4e2a\u751f\u7269\u7c7b\u4f3c\u836f\u90fd\u662f\u672a\u6765\u5236\u836f\u884c\u4e1a\u589e\u901f\u6700\u5feb\u7684\u9886\u57df\u4e4b\u4e00\u3002\u800c\u5bf9\u4e8e\u590d\u5b8f\u6c49\u9716\u6765\u8bf4\uff0c\u8fdb\u5c55\u6700\u5feb\u7684\u56db\u4e2a\u4ea7\u54c1\u90fd\u662f\u5168\u7403\u9500\u552e\u989d\u524d\u5341\u836f\u54c1\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u3002<\/span><\/p>\n

\"\u590d\u5b8f\u6c49\u9716\uff1a\u5982\u4f55\u4ece\u751f\u7269\u79d1\u6280\u516c\u53f8\u4e2d\u8131\u9896\u800c\u51fa\uff1f\"<\/p>\n

\u4e8c\u3001\u9762\u5bf9\u5355\u6297\u9886\u57df\u6fc0\u70c8\u7684\u7ade\u4e89\uff0c\u590d\u5b8f\u6c49\u9716\u5982\u4f55\u8131\u9896\u800c\u51fa\uff1f<\/span><\/p>\n

2.1 \u5355\u6297\u9886\u57df\u7684\u7ade\u4e89\u4e0d\u5bb9\u5ffd\u89c6<\/span><\/p>\n

\u7531\u4e8e\u5de8\u5927\u7684\u5546\u4e1a\u6f5c\u529b\uff0c\u5355\u6297\u9886\u57df\u4e5f\u5438\u5f15\u4e86\u56fd\u5185\u8bb8\u591a\u836f\u4f01\u4e89\u76f8\u5e03\u5c40\u3002\u4ee5\u516c\u53f8\u8fdb\u5c55\u6700\u5feb\u76844\u4e2a\u5355\u6297\u836f\u7269\u6765\u8bf4\uff0c\u6bcf\u4e2a\u9776\u70b9\u5747\u6709\u591a\u5bb6\u4f01\u4e1a\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u8fdb\u5165\u4e09\u671f\u4e34\u5e8a\u6216\u8005\u66f4\u665a\uff0c\u4e8c\u671f\/\u4e00\u671f\u4e34\u5e8a\u9636\u6bb5\u7684\u4f01\u4e1a\u66f4\u591a\u3002\u516c\u53f8\u5728\u8fd9\u51e0\u4e2a\u70ed\u95e8\u5355\u6297\u5747\u9762\u4e34\u8f83\u4e3a\u6fc0\u70c8\u7684\u7ade\u4e89\u538b\u529b\uff0c\u5c24\u5176\u662fTNF-\u03b1\u5355\u6297\u548cVEGF\u5355\u6297\uff0c\u7ade\u4e89\u975e\u5e38\u6fc0\u70c8\u3002<\/span><\/p>\n

\"\u590d\u5b8f\u6c49\u9716\uff1a\u5982\u4f55\u4ece\u751f\u7269\u79d1\u6280\u516c\u53f8\u4e2d\u8131\u9896\u800c\u51fa\uff1f\"<\/p>\n


<\/p>\n

2.2 \u590d\u5b8f\u6c49\u9716\u5982\u4f55\u8131\u9896\u800c\u51fa\uff1f<\/span><\/p>\n

 (1) \u540c\u7c7b\u516c\u53f8\u4e2d\u5546\u4e1a\u5316\u4ea7\u80fd\u5f3a<\/span><\/p>\n

\u4ece\u4e0a\u8868\u4e2d\uff0c\u6211\u4eec\u53ef\u4ee5\u53d1\u73b0\u590d\u5b8f\u6c49\u9716\u7684\u56db\u4e2a\u5546\u4e1a\u5316\u8fdb\u5c55\u6700\u5feb\u7684\u5355\u6297\u867d\u7136\u9762\u4e34\u6fc0\u70c8\u7684\u7ade\u4e89\uff0c\u4f46\u662f\u5176\u7ade\u4e89\u5bf9\u624b\u5927\u90e8\u5206\u90fd\u662f\u4e0e\u516c\u53f8\u7c7b\u4f3c\u7684Biotech\u516c\u53f8\u3002\u4e5f\u5c31\u662f\u8bf4\uff0c\u8fd9\u4e9b\u7ade\u4e89\u5bf9\u624b\u4e2d\uff0c\u76ee\u524d\u5c31\u5df2\u5177\u5907\u5546\u4e1a\u5316\u80fd\u529b\u7684\u516c\u53f8\u5f88\u5c11\u3002\u800c\u5728\u5546\u4e1a\u5316\u7684\u6bd4\u62fc\u4e2d\uff0c\u77ed\u671f\u7684\u4ea7\u80fd\u95ee\u9898\u5c06\u662f\u5404\u5bb6\u516c\u53f8\u9762\u5bf9\u7684\u7b2c\u4e00\u9053\u5173\u53e3\u3002<\/span><\/p>\n

\u590d\u5b8f\u6c49\u9716\u76ee\u524d\u5728\u4e0a\u6d77\u5f90\u6c47\u5df2\u7ecf\u5efa\u6210\u4e00\u671f\u751f\u4ea7\u57fa\u5730\uff0c\u5360\u5730\u7ea611000\u5e73\u7c73\uff0c\u67096\u53f02000\u5347\u548c2\u53f0500\u5347\u7684\u4e00\u6b21\u6027\u751f\u7269\u53cd\u5e94\u5668\uff0c\u51711.3\u4e07\u5347\u7684\u4ea7\u80fd\uff0c\u5728\u56fd\u5185\u540c\u7c7b\u578bBiotech\u516c\u53f8\u4e2d\u5904\u4e8e\u9886\u5148\u5730\u4f4d\u3002\u800c\u4e14\u516c\u53f8\u91c7\u7528\u7684\u662f\u4e00\u6b21\u6027\u751f\u7269\u53cd\u5e94\u5668\uff0c\u76f8\u6bd4\u4f20\u7edf\u7684\u4e0d\u9508\u94a2\u751f\u7269\u53cd\u5e94\u5668\uff0c\u5177\u6709\u505c\u5de5\u671f\u77ed\u3001\u6e05\u6d17\u53ca\u6d88\u6bd2\u5de5\u4f5c\u5c11\u3001\u4ea4\u53c9\u6c61\u67d3\u4f4e\u7b49\u8bf8\u591a\u4f18\u70b9\u3002<\/span><\/p>\n

\u6b64\u5916\uff0c\u516c\u53f8\u6b63\u5728\u89c4\u5212\u4e8e\u677e\u6c5f\u5efa\u7acb\u4e8c\u671f\u751f\u4ea7\u57fa\u5730\uff0c\u4ee5\u7ee7\u7eed\u5927\u5e45\u63d0\u9ad8\u4ea7\u80fd\u6765\u6ee1\u8db3\u672a\u6765\u7684\u5168\u7403\u5316\u5546\u4e1a\u9700\u6c42\u3002<\/span><\/p>\n

\"\u590d\u5b8f\u6c49\u9716\uff1a\u5982\u4f55\u4ece\u751f\u7269\u79d1\u6280\u516c\u53f8\u4e2d\u8131\u9896\u800c\u51fa\uff1f\"<\/p>\n

\u5728\u5355\u6297\u836f\u7269\u4e3b\u8981\u7684\u6cbb\u7597\u9886\u57df\u4e2d\uff0c\u65e0\u8bba\u662f\u764c\u75c7\u3001\u8fd8\u662f\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u4e34\u5e8a\u4e0a\u5747\u5b58\u5728\u5f88\u5927\u7684\u672a\u6ee1\u8db3\u9700\u6c42\uff0c\u800c\u8fd9\u4e9bBiotech\u516c\u53f8\u73b0\u6709\u7684\u4ea7\u80fd\u90fd\u8fdc\u65e0\u6cd5\u6ee1\u8db3\u5e02\u573a\u73b0\u5b58\u7684\u9700\u6c42\u3002\u8fd9\u4e5f\u5c31\u610f\u5473\u7740\uff0c\u5728\u77ed\u671f\u6811\u7acb\u516c\u53f8\u54c1\u724c\u3001\u62a2\u5360\u5e02\u573a\u4efd\u989d\u7684\u7ade\u4e89\u4e2d\uff0c\u4ea7\u80fd\u662f\u975e\u5e38\u5173\u952e\u7684\u4e00\u73af\u3002\u800c\u590d\u5b8f\u6c49\u9716\u7684\u4ea7\u80fd\u662f\u76ee\u524dH\u80a1Biotech\u516c\u53f8\u4e2d\u6700\u5927\u7684\uff0c\u5bf9\u516c\u53f8\u540e\u7eed\u7684\u53d1\u5c55\u6709\u5f88\u5927\u7684\u5e2e\u52a9\u3002<\/span><\/p>\n

\uff082\uff09\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\u7ecf\u9a8c<\/span><\/p>\n

\u76ee\u524d\u56fd\u5185\u7684\u5236\u836f\u516c\u53f8\u771f\u6b63\u5b9e\u73b0\u5168\u7403\u5316\u7684\u53ef\u4ee5\u8bf4\u57fa\u672c\u6ca1\u6709\uff0c\u4e3b\u8981\u539f\u56e0\u5c31\u662f\u56fd\u5185\u7684\u5316\u5b66\u836f\u4e0e\u56fd\u9645\u836f\u4f01\u5728\u8d28\u91cf\u548c\u65f6\u95f4\u4e0a\u5dee\u8ddd\u592a\u5927\u3002\u800c\u4ee5\u5355\u6297\u4e3a\u4ee3\u8868\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u5219\u4e0e\u56fd\u9645\u836f\u4f01\u6ca1\u6709\u592a\u5927\u7684\u65f6\u95f4\u5dee\u8ddd\uff0c\u5728\u8d28\u91cf\u4e0a\u56fd\u5185\u7684\u836f\u4f01\u4e5f\u5927\u90fd\u5f00\u59cb\u6309\u7167\u5168\u7403\u6807\u51c6\u8fdb\u884c\u7814\u5236\uff0c\u6240\u4ee5\uff0c\u5236\u836f\u884c\u4e1a\u5b8c\u5168\u6709\u673a\u4f1a\u5728\u5355\u6297\u7b49\u9886\u57df\u5b9e\u73b0\u56fd\u9645\u5316\u3002<\/span><\/p>\n

\u8981\u5b9e\u73b0\u56fd\u9645\u5316\uff0c\u73b0\u9636\u6bb5\u6700\u9996\u8981\u7684\u6beb\u65e0\u7591\u95ee\u662f\u8981\u5177\u5907\u63a8\u8fdb\u5168\u7403\u591a\u4e2d\u5fc3\u4e34\u5e8a\u53ca\u6ce8\u518c\u7684\u80fd\u529b\u3002\u590d\u5b8f\u6c49\u9716\u76ee\u524d\u5df2\u7ecf\u5728\u516d\u4e2a\u4e0d\u540c\u53f8\u6cd5\u6743\u533a\u540c\u65f6\u8fdb\u884c\u5341\u9879\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u62e5\u6709\u8d85\u8fc7100\u540d\u4e34\u5e8a\u53ca\u533b\u5b66\u4e8b\u52a1\u4eba\u5458\u3002\u540c\u65f6\uff0c\u5728\u836f\u54c1\u8d28\u91cf\u65b9\u9762\uff0c\u516c\u53f8\u751f\u4ea7\u57fa\u5730\u5df2\u901a\u8fc7\u6b27\u76dfQP\u8ba4\u8bc1\uff0c\u6574\u4e2a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7b26\u5408\u7f8e\u56fd\u3001\u6b27\u76df\u548c\u4e2d\u56fd\u7684\u8d28\u91cf\u6807\u51c6\uff0c\u4e3a\u65e5\u540e\u7684\u5168\u7403\u5546\u4e1a\u5316\u6253\u4e0b\u57fa\u7840\u3002\u6700\u540e\uff0c\u5728\u9500\u552e\u65b9\u9762\uff0c\u516c\u53f8\u4e5f\u4e0eAccord\u3001Cipla\u7b49\u516c\u53f8\u5c31\u56fd\u9645\u5e02\u573a\u5c55\u5f00\u4e86\u5408\u4f5c\u3002<\/span><\/p>\n

\uff083\uff09\u590d\u661f\u533b\u836f\u7684\u9500\u552e\u4e0e\u7814\u53d1\u652f\u6301<\/span><\/p>\n

\u53e6\u5916\uff0c\u4e0e\u5176\u4ed6Biotech\u516c\u53f8\u4e0d\u540c\u7684\u662f\uff0c\u51ed\u501f\u6bcd\u516c\u53f8\u590d\u661f\u533b\u836f\u7684\u8d44\u6e90\uff0c\u590d\u5b8f\u6c49\u9716\u65e9\u671f\u7684\u5546\u4e1a\u5316\u63a8\u5e7f\u4f1a\u66f4\u5bb9\u6613\u4e00\u4e9b\u3002\u590d\u661f\u533b\u836f\u4f5c\u4e3a\u56fd\u5185\u5236\u836f\u884c\u4e1a\u7684\u4f7c\u4f7c\u8005\uff0c\u5176\u5b8c\u5584\u7684\u5e02\u573a\u51c6\u5165\u548c\u9500\u552e\u7f51\u7edc\u5c06\u5e2e\u52a9\u516c\u53f8\u5728\u65e9\u671f\u5feb\u901f\u62d3\u5c55\u5e02\u573a\u3001\u6253\u9020\u54c1\u724c\u77e5\u540d\u5ea6\u3002<\/span><\/p>\n

\"\u590d\u5b8f\u6c49\u9716\uff1a\u5982\u4f55\u4ece\u751f\u7269\u79d1\u6280\u516c\u53f8\u4e2d\u8131\u9896\u800c\u51fa\uff1f\"<\/p>\n

\u4e0e\u6b64\u540c\u65f6\uff0c\u516c\u53f8\u81ea\u8eab\u4e5f\u5728\u5efa\u7acb\u4e00\u652f\u4e13\u4e1a\u9ad8\u6548\u7684\u5546\u4e1a\u5316\u56e2\u961f\uff0c\u6bd4\u5982\u5c31\u5728\u524d\u4e24\u5929\uff0c\u516c\u53f8\u4ece\u5b89\u8fdb\u6316\u6765\u4e00\u5458\u5927\u5c06\u2014\u2014\u539f\u5b89\u8fdb\u4e2d\u56fd\u533a\u603b\u7ecf\u7406\uff0c\u62c5\u4efb\u516c\u53f8\u9ad8\u7ea7\u526f\u603b\u88c1\u548c\u9996\u5e2d\u5546\u4e1a\u8fd0\u8425\u5b98\u3002\u800c\u5176\u4ed6Biotech\u516c\u53f8\u5927\u591a\u90fd\u53ea\u80fd\u81ea\u5df1\u4ece\u5934\u7ec4\u5efa\u5546\u4e1a\u5316\u56e2\u961f\uff0c\u5728\u6ee1\u662f\u7a7a\u767d\u7684\u5355\u6297\u5e02\u573a\u4e2d\uff0c\u590d\u5b8f\u6c49\u9716\u518d\u6b21\u5360\u636e\u4e86\u5148\u53d1\u4f18\u52bf\u3002<\/span><\/p>\n

\u4ee5\u5229\u59a5\u6614\u5355\u6297\u4e3e\u4f8b\uff0c\u516c\u53f8\u5c31HLX01\u4e0e\u590d\u661f\u533b\u836f\u7b7e\u8ba2\u4e86\u5408\u4f5c\u9500\u552e\u534f\u8bae\uff1a\u516c\u53f8\u8d1f\u8d23\u5177\u4f53\u7684\u7814\u53d1\u4e0e\u751f\u4ea7\uff0c\u590d\u661f\u533b\u836f\u5219\u8d1f\u8d23\u62a5\u9500\u4e34\u5e8a\u5f00\u53d1\u652f\u51fa\uff0c\u5e76\u8d1f\u8d23\u5546\u4e1a\u5316\u4e2d\u56fd\u533a\u7684\u6743\u76ca\u3002\u4ece\u7814\u53d1\u5230\u5546\u4e1a\u5316\u63a8\u5e7f\uff0c\u516c\u53f8\u5728\u591a\u4e2a\u73af\u8282\u90fd\u5c06\u4eab\u53d7\u5230\u590d\u661f\u533b\u836f\u7684\u8d44\u6e90\uff0c\u5728\u4e0e\u5176\u4ed6Biotech\u516c\u53f8\u7ade\u4e89\u4e2d\u5360\u636e\u4f18\u52bf\u3002<\/span><\/p>\n

(4) \u5168\u4ea7\u4e1a\u94fe\u4f18\u52bf<\/span><\/p>\n

\u6700\u540e\uff0c\u4e0e\u56fd\u5185\u5176\u4ed6Biotech\u516c\u53f8\u4e0d\u540c\u7684\u662f\uff0c\u590d\u5b8f\u6c49\u9716\u662f\u4e00\u5bb6\u7efc\u5408\u4e00\u4f53\u5316\u7684\u751f\u7269\u5236\u836f\u516c\u53f8\u3002\u9996\u5148\uff0c\u516c\u53f8\u5728\u4e2d\u56fd\u4e0a\u6d77\u3001\u4e2d\u56fd\u53f0\u5317\u4ee5\u53ca\u7f8e\u56fd\u52a0\u5dde\u5747\u8bbe\u6709\u7814\u53d1\u4e2d\u5fc3\uff0c\u62e5\u6709\u5168\u7403\u4e00\u4f53\u5316\u7684\u7814\u53d1\u5e73\u53f0\uff1b\u5176\u6b21\uff0c\u516c\u53f8\u5728\u5168\u7403\u591a\u4e2a\u53f8\u6cd5\u6743\u533a\u5747\u6709\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5177\u5907\u5168\u7403\u836f\u653f\u6ce8\u518c\u4e0e\u4e34\u5e8a\u5f00\u53d1\u80fd\u529b\uff1b\u751f\u4ea7\u65b9\u9762\uff0c\u51ed\u501f\u5168\u65b9\u4f4d\u7684\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\u548c\u9ad8\u6548\u7684\u4e00\u6b21\u6027\u751f\u4ea7\u6280\u672f\uff0c\u516c\u53f8\u80fd\u591f\u4e3a\u60a3\u8005\u63d0\u4f9b\u4ef7\u5ec9\u4f46\u8d28\u4f18\u7684\u751f\u7269\u836f\uff1b\u6700\u540e\uff0c\u901a\u8fc7\u81ea\u8eab\u9010\u6e10\u58ee\u5927\u7684\u5e02\u573a\u56e2\u961f\u4ee5\u53ca\u4e0e\u56fd\u9645\u836f\u4f01\u7684\u5408\u4f5c\uff0c\u516c\u53f8\u672a\u6765\u7684\u5b9a\u4f4d\u662f\u8986\u76d6\u5168\u7403\u5e02\u573a\u7684\u751f\u7269\u533b\u836f\u4f01\u4e1a\u3002<\/span><\/p>\n

\u8fd9\u79cd\u4f9d\u9760\u9ad8\u6548\u81ea\u4e3b\u521b\u65b0\u80fd\u529b\u8d2f\u7a7f\u751f\u7269\u533b\u836f\u5168\u4ea7\u4e1a\u94fe\u7684\u4f18\u52bf\uff0c\u4e5f\u5c06\u5e2e\u52a9\u516c\u53f8\u5728\u7ade\u4e89\u6fc0\u70c8\u7684\u5355\u6297\u9886\u57df\u8131\u9896\u800c\u51fa\u3002<\/span><\/p>\n

2.3 \u52a1\u5b9e\u7684\u73b0\u91d1\u6d41\u54c1\u79cd\u5148\u884c<\/span><\/strong><\/span><\/p>\n

\u4e0e\u767e\u6d4e\u795e\u5dde\u3001\u534e\u9886\u533b\u836f\u7b49\u5176\u5b83Biotech\u516c\u53f8\u4e0d\u592a\u4e00\u6837\u7684\u662f\uff0c\u516c\u53f8\u76ee\u524d\u8fdb\u5c55\u6700\u5feb\u7684\u54c1\u79cd\u90fd\u662f\u4e34\u5e8a\u4e0a\u5df2\u7ecf\u6709\u8f83\u9ad8\u5171\u8bc6\u7684\u751f\u7269\u7c7b\u4f3c\u836f\uff0c\u8fd9\u4e9b\u54c1\u79cd\u5c06\u7ed9\u516c\u53f8\u5728\u77ed\u4e2d\u671f\u5e26\u6765\u53ef\u89c2\u7684\u73b0\u91d1\u6d41\u3002\u8fd9\u5bf9\u4e8e\u516c\u53f8\u7684\u8d22\u52a1\u4ee5\u53ca\u540e\u7eed\u521b\u65b0\u836f\u4e0e\u8054\u5408\u7597\u6cd5\u7684\u5f00\u53d1\u90fd\u5927\u6709\u88e8\u76ca\u3002<\/span><\/p>\n

\u6bd4\u5982\uff0c\u9664\u4e86\u5df2\u7ecf\u4e0a\u5e02\u7684\u6c49\u5229\u5eb7\uff0c\u516c\u53f8\u73b0\u6709\u7684\u66f2\u59a5\u73e0\u5355\u6297\u7c7b\u4f3c\u836f\u3001\u963f\u8fbe\u6728\u5355\u6297\u7c7b\u4f3c\u836f\u4ee5\u53ca\u5b89\u7ef4\u6c40\u5355\u6297\u7c7b\u4f3c\u836f\uff0c\u5747\u5904\u4e8e\u4e34\u5e8a\u4e09\u671f\/\u7533\u62a5\u4e0a\u5e02\u9636\u6bb5\u3002\u4e0e\u5229\u59a5\u6614\u5355\u6297\u7c7b\u4f3c\uff0c\u8fd9\u51e0\u6b3e\u5355\u6297\u76ee\u524d\u4e5f\u90fd\u6709\u5f88\u5927\u7684\u5e02\u573a\u9700\u6c42\u5c1a\u672a\u91ca\u653e\uff0c\u540c\u65f6\u4e5f\u90fd\u662f\u5728\u4e34\u5e8a\u4e0a\u6709\u8f83\u9ad8\u5171\u8bc6\u7684\u4ea7\u54c1\uff0c\u4f30\u8ba1\u90fd\u4f1a\u6709\u8f83\u5feb\u7684\u653e\u91cf\u901f\u5ea6\u3002<\/span><\/p>\n

\u51ed\u501f\u4f4e\u98ce\u9669\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u5b58\u6d3b\u4e0b\u6765\u5e76\u79ef\u7d2f\u4e00\u5b9a\u7684\u73b0\u91d1\u6d41\uff0c\u540e\u7eed\u518d\u901a\u8fc7\u7ba1\u7ebf\u91cc\u7684\u521b\u65b0\u836f\u4e0e\u8054\u5408\u7597\u6cd5\u5b9e\u73b0\u8fdb\u9636\u3002\u6216\u8bb8\u590d\u5b8f\u6c49\u9716\u8fd9\u79cd\u6a21\u5f0f\u66f4\u9002\u5408\u521d\u521b\u578b\u751f\u7269\u533b\u836f\u516c\u53f8\uff0c\u4e5f\u66f4\u9002\u5408\u5f53\u524d\u4e2d\u56fd\u7684\u57fa\u672c\u56fd\u60c5\u3002<\/span><\/p>\n

\u4e09\u3001\u603b\u7ed3<\/strong><\/span><\/p>\n

\u5728\u836f\u4f01\u4e89\u76f8\u5e03\u5c40\u521b\u65b0\u3001\u8d44\u672c\u5e02\u573a\u70ed\u6f6e\u6d8c\u52a8\u7684\u4eca\u5929\uff0c\u590d\u5b8f\u6c49\u9716\u7684\u53d1\u5c55\u7b56\u7565\u5374\u66f4\u63a5\u5730\u6c14\uff1a\u77ed\u671f\u751f\u7269\u7c7b\u4f3c\u836f\u4f9d\u9760\u4ea7\u80fd\u4e0e\u5546\u4e1a\u5316\u4f18\u52bf\u62d4\u5f97\u5934\u7b79\uff0c\u957f\u671f\u8054\u5408\u7597\u6cd5\u7684\u5f00\u53d1\u4e0e\u56fd\u9645\u5316\u5e03\u5c40\u5e2e\u52a9\u516c\u53f8\u5728\u66f4\u957f\u7684\u65f6\u671f\u91cc\u6301\u7eed\u53d1\u5c55\u3002<\/span><\/p>\n

\u603b\u4e4b\uff0c\u6211\u4eec\u5bf9\u590d\u5b8f\u6c49\u9716\u5728\u5355\u6297\u9886\u57df\u7684\u7ade\u4e89\u4e2d\u8131\u9896\u800c\u51fa\u6ee1\u6000\u671f\u5f85\uff01<\/span><\/p>\n

\u57f9\u8bad\u63a8\u8350<\/span><\/strong><\/span>
<\/p>\n

\u836f\u4f01\u516c\u7528\u5de5\u7a0b\u8bbe\u8ba1\u3001\u9a8c\u8bc1\u53ca\u65e5\u5e38\u7ba1\u7406\u7ef4\u62a4\uff08\u6b66\u6c49\uff09\u6280\u672f\u4ea4\u6d41\u4f1a<\/span><\/strong><\/span><\/a>
<\/p>\n

\u836f\u4f01\u5982\u4f55\u5f00\u5c55\u4e34\u5e8a\u524d\u5b89\u5168\u6027\u7814\u7a76\u4e13\u9898\u57f9\u8bad\u73ed\uff08ICH S\u6307\u5bfc\uff09<\/span><\/strong><\/span><\/a>
<\/p>\n

\u201c\u8d28\u91cf\u5de5\u7a0b\u5e08\uff08QA)\u7684\u81ea\u6211\u4fee\u517b\u4e0e\u63d0\u5347\u201d\uff08\u6c88\u9633\uff09\u6280\u672f\u4ea4\u6d41\u4f1a<\/span><\/strong><\/span><\/a><\/p>\n

\u65b0\u6cd5\u89c4\u4e0b\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u7684\u91cd\u70b9\u96be\u70b9\u5206\u6790\u4e13\u9898\u7814\u4fee\u73ed<\/a><\/span><\/strong><\/span><\/p>\n

\u8bc6\u522b\u5fae\u4fe1\u4e8c\u7ef4\u7801\uff0c\u6dfb\u52a0\u5c0f\u7f16\uff0c\u7b26\u5408\u6761\u4ef6\u8005\u5373\u53ef\u52a0\u5165\u751f\u7269\u5236\u54c1\u5fae\u4fe1\u7fa4\uff01<\/strong><\/p>\n

\n
\n

\u8bf7\u6ce8\u660e\uff1a\u59d3\u540d+\u7814\u7a76\u65b9\u5411\uff01<\/strong><\/span><\/p>\n

\n
\n

\"\u590d\u5b8f\u6c49\u9716\uff1a\u5982\u4f55\u4ece\u751f\u7269\u79d1\u6280\u516c\u53f8\u4e2d\u8131\u9896\u800c\u51fa\uff1f\"<\/p>\n

\"\u590d\u5b8f\u6c49\u9716\uff1a\u5982\u4f55\u4ece\u751f\u7269\u79d1\u6280\u516c\u53f8\u4e2d\u8131\u9896\u800c\u51fa\uff1f\"
<\/p>\n<\/section>\n<\/section>\n

\n
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<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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<\/section>\n<\/section>\n
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\u7248<\/section>\n<\/section>\n
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\u6743<\/section>\n<\/section>\n
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\u58f0<\/section>\n<\/section>\n
\n
\u660e<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u672c\u516c\u4f17\u53f7\u6240\u6709\u8f6c\u8f7d\u6587\u7ae0\u7cfb\u51fa\u4e8e\u4f20\u9012\u66f4\u591a\u4fe1\u606f\u4e4b\u76ee\u7684\uff0c\u4e14\u660e\u786e\u6ce8\u660e\u6765\u6e90\u548c\u4f5c\u8005\uff0c\u4e0d\u5e0c\u671b\u88ab\u8f6c\u8f7d\u7684\u5a92\u4f53\u6216\u4e2a\u4eba\u53ef\u4e0e\u6211\u4eec\u8054\u7cfb(cbplib@163.com)\uff0c\u6211\u4eec\u5c06\u7acb\u5373\u8fdb\u884c\u5220\u9664\u5904\u7406\u3002\u6240\u6709\u6587\u7ae0\u4ec5\u4ee3\u8868\u4f5c\u8005\u89c2\u70b9\uff0c\u4e0d\u4ee3\u8868\u672c\u7ad9\u7acb\u573a\u3002<\/span>
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